FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
90049–90072 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 09, 1998
ADC COMPACT (AGFA DIAGNOSTIC CENTER)
K974597 · KPR
Bayer Corp., Agfa Div.
Radiology · 90d
Cleared Mar 09, 1998
DAUM NEUROBIOPSY NEEDLE
K974631 · KNW
Daum Corp.
Gastroenterology & Urology · 87d
Cleared Mar 09, 1998
PERSYST PRISM
K974718 · GWS
Persyst Development Corp.
Neurology · 82d
Cleared Mar 09, 1998
HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE
K974758 · JOL
Hydrox Laboratories
General Hospital · 80d
Cleared Mar 09, 1998
HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE
K974759 · JOL
Hydrox Laboratories
General Hospital · 80d
Cleared Mar 09, 1998
COHERENT ULTRAPULSE S SERIES CO2 SURGICAL LASERS MODEL C AND L
K974789 · GEX
Lumenis, Inc.
General & Plastic Surgery · 77d
Cleared Mar 09, 1998
ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS)
K980022 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 63d
Cleared Mar 09, 1998
SMITH & NEPHEW DYONICS INTELIJET REUSABLE CANNULAS
K980092 · FRN
Smith & Nephew, Inc.
General Hospital · 59d
Cleared Mar 09, 1998
CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET
K980123 · GCJ
Louisville Laboratories, Inc.
General & Plastic Surgery · 54d
Cleared Mar 09, 1998
FLOWABLE HYBRID
K980298 · EBD
Cosmedent, Inc.
Dental · 41d
Cleared Mar 09, 1998
NON-WOVEN COMPRESS
K980382 · KMF
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 35d
Cleared Mar 09, 1998
CARRARA PDF, CARRARA H, CARRARA R
K980597 · EJT
European Dental Imports, Inc.
Dental · 20d
Cleared Mar 09, 1998
PROGOLD ELECTROCOPING SYSTEM
K980613 · EJT
Micro Dental Laboratories
Dental · 19d
Cleared Mar 06, 1998
AMPLATZ GOOSE NECK SNARE KIT/ CATHETER
K972511 · DXE
Microvena Corp.
Cardiovascular · 246d
Cleared Mar 06, 1998
RANDOX CREATININE
K973993 · CGX
Randox Laboratories, Ltd.
Chemistry · 136d
Cleared Mar 06, 1998
DAUM NEUROPUNCTURE NEEDLE
K974574 · KNW
Daum Corp.
Gastroenterology & Urology · 88d
Cleared Mar 06, 1998
DAUM ASPIRATIONBIOPSY NEEDLE
K974575 · KNW
Daum Corp.
Gastroenterology & Urology · 88d
Cleared Mar 06, 1998
DAUM BIOPSYGUN
K974576 · KNW
Daum Corp.
Gastroenterology & Urology · 88d
Cleared Mar 06, 1998
IF-727 INTERFERENTIAL STIMULATOR
K974585 · LIH
Skylark Device Co., Ltd.
Neurology · 88d
Cleared Mar 06, 1998
TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC
K974751 · ESD
General Hearing Instruments, Inc.
Ear, Nose, Throat · 77d
Cleared Mar 06, 1998
DIAMEDIX IS-RF TEST SYSTEM
K974889 · DHR
Diamedix Corp.
Immunology · 66d
Cleared Mar 06, 1998
CARESIDE ANALYZER
K980056 · JJF
Exigent Diagnostics, Inc.
Chemistry · 59d
Cleared Mar 06, 1998
ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM)
K980190 · MOI
Chiron Corp.
Immunology · 45d
Cleared Mar 06, 1998
OSTEOMARK
K980518 · JMM
Ostex Intl., Inc.
Chemistry · 49d